CollaGenex Pharmaceuticals Announces Expected Third Quarter Results.Business Editors NEWTOWN, Pa.--(BUSINESS WIRE)--Oct. 3, 2000 CollaGenex Pharmaceuticals, Inc. today announced that it anticipates a loss in the third quarter of 2000 of $0.23 to $0.26 per basic and diluted share compared to a loss of $0.43 per basic and diluted share in the third quarter of 1999 and a loss of $0.27 per basic and diluted share in the second quarter of 2000. While the current annualized annualized Of or relating to a variable that has been mathematically converted to a yearly rate. Inflation and interest rates are generally annualized since it is on this basis that these two variables are ordinarily stated and compared. sales value of Periostat prescriptions filled in August is about $24 million, or about $6 million per quarter, Periostat net sales Net Sales The amount a seller receives from the buyer after costs associated with the sale are deducted. Notes: This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight for the third quarter of 2000 are currently expected to be $4.2 million. Periostat net sales were $4.2 million in the third quarter of 1999 and $5.7 million in the second quarter of 2000. Factors influencing Periostat sales: -- CollaGenex sells Periostat to wholesalers and large drug store chains, who then distribute the drug to pharmacies. Wholesalers generally maintain higher inventory levels during periods of strong growth in end user demand and lower inventory levels when growth in demand is slower. -- The strong growth that Periostat experienced during 1999 led to relatively high inventory levels in wholesalers. In addition, wholesalers and large drug store chains increased inventories in advance of a price increase during the fourth quarter of 1999. During the first and second quarters of 2000, wholesale buying continued to be slightly higher than estimated end user demand. -- As the rate of growth in end user demand slowed during 2000, wholesalers have reduced their weeks of sales in inventories and have drawn down existing inventories to meet demand, rather than placing new orders. Total net revenues for the third quarter of 2000 are expected to be $5.4 million compared to $4.3 million in the third quarter of 1999 and $6.7 million in the second quarter of 2000. Total net revenues in the third quarter of 2000 reflect strong growth in contract revenues, particularly co-promotion revenues for Vioxx, a Merck & Co. drug that CollaGenex promotes for the treatment of acute dental pain. "While it is disappointing that fluctuations in wholesaler demand will result in lower net sales of Periostat than in the previous quarter," said Brian M. Gallagher, PhD, chairman, chief executive officer and president of CollaGenex, "it is encouraging that, despite a reduction in the number of procedures carried out in the dentists' offices during the summer, prescription demand increased modestly from the second to the third quarter of 2000. However, while more than 700,000 prescriptions have been filled for Periostat since launch, this still represents a very small penetration of our market, which is the 67 million adults in the U.S. who have periodontal disease Periodontal Disease Definition Periodontal diseases are a group of diseases that affect the tissues that support and anchor the teeth. Left untreated, periodontal disease results in the destruction of the gums, alveolar bone (the part of the jaws where , including the 13 million who actively seek treatment each year." "Based on market research," Dr. Gallagher continued, "we know that the rate of adoption of Periostat by the dental community has slowed in 2000 primarily because many doctors have chosen to prescribe Periostat for only a subset of their eligible patients, typically their most advanced or refractory refractory Material that is not deformed or damaged by high temperatures, used to make crucibles, incinerators, insulation, and furnaces, particularly metallurgical furnaces. cases. Other dentists have simply been slow to accept a new pharmaceutical therapy for a disease they are accustomed to treating solely with mechanical procedures. However, a growing number of dental professionals are prescribing Periostat more broadly, and we are confident that we will be able to expand the usage of an increasing number of dentists. Recently published results of our pivotal Phase III clinical trials Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the in the Journal of Periodontology The Journal of Periodontology is the learned journal of the American Academy of Periodontology (AAP). External Links The Journal of Periodontology , the official publication of the American Academy of Periodontology American Academy of Periodontology (AAP), n.pr a nonprofit professional association of dental professionals specializing in the prevention, diagnosis, and treatment of diseases affecting the periodontium and in the placement and maintenance of dental implants. , have confirmed the safety and efficacy of Periostat in a broad patient population." Actions to increase end user demand: -- Direct-to-consumer advertising direct-to-consumer advertising Drug industry The use of mass media–eg, TV, magazines, newspapers, to publicly promote drugs, medical devices or other products which, by law, require a prescription, which targets consumers, with the intent of having a Pt campaign. In early October 2000, we will launch a direct-to-consumer advertising test campaign in Tampa and St. Louis for a three month trial period. Market research conducted on our behalf by Bozell Healthcare, one of the largest healthcare advertising agencies in the world, has revealed that, among patients with adult periodontitis periodontitis Inflammation of soft tissues around the teeth (see tooth). Poor dental hygiene leads to deposition of bacterial plaque on the teeth below the gum line, irritating and eroding nearby tissues. , there is less than a 10% awareness that a pill exists to treat their disease safely and effectively. This contrasts to more than 90% awareness of Periostat by dentists, who have been the focus of our marketing efforts. Many of the patients in this study also indicated that upon seeing an advertisement they would ask their dentist about Periostat. DTC DTC See: Depository Transfer Check DTC See: Depository Trust Company DTC See Depository Trust Company (DTC). advertising has significantly increased the sales of other prescription products. If the results of this two-city test are favorable, we intend to roll-out a national campaign in early 2001. -- Expanded Use Initiative. In June of this year we implemented an Expanded Use Initiative designed to educate dentists on the benefits Periostat offers to all of their patients with adult periodontitis. This program illustrates how earlier disease intervention using Periostat can halt the progression of mild/moderate periodontal disease to severe disease. The program also highlights how Periostat can be a practice builder and revenue generator for dentists by increasing patient satisfaction and improving patients' oral health sufficiently to allow for increased dental restorative re·stor·a·tive adj. 1. Of or relating to restoration. 2. Tending or having the power to restore. n. A medicine or other agent that helps to restore health, strength, or consciousness. work. CollaGenex will be hosting a conference call for the investment community today at 9:15 A.M. Eastern time. The dial-in number is 800-982-3654. The international dial-in number is 703-871-3021. A replay of the call will be available through October 12, 2000. The replay number is 888-266-2086, passcode 4643533. The international replay number is 703-925-2435, passcode 4643533. The conference call will also be simulcast over the Internet at www.vcall.com and will be archived on the company's web site at www.collagenex.com. CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on providing innovative medical therapies to the dental market. The company's lead product, Periostat(R), was approved by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. in September 1998 and is the first and only pharmaceutical to treat periodontal disease by inhibiting the enzymes that destroy periodontal periodontal /peri·odon·tal/ (per?e-o-don´t'l) 1. pertaining to the periodontal ligament or periodontium. 2. near or around a tooth. per·i·o·don·tal adj. 1. support tissues. Periostat is marketed to the dental community by CollaGenex through a professional pharmaceutical sales force composed of approximately 120 sales representatives and managers. Currently, the company's dental sales force is also marketing Vioxx and Denavir. Research has shown that the enzyme-suppression technology underlying Periostat may also be applicable to other diseases involving destruction of the body's connective connective - An operator used in logic to combine two logical formulas. See first order logic. tissues, including cancer metastasis metastasis /me·tas·ta·sis/ (me-tas´tah-sis) pl. metas´tases 1. transfer of disease from one organ or part of the body to another not directly connected with it, due either to transfer of pathogenic microorganisms or to , osteoporosis osteoporosis (ŏs'tēō'pərō`sĭs), disorder in which the normal replenishment of old bone tissue is severely disrupted, resulting in weakened bones and increased risk of fracture; osteopenia , osteoarthritis osteoarthritis or osteoarthrosis or degenerative joint disease Most common joint disorder, afflicting over 80% of those who reach age 70. It does not involve excessive inflammation and may have no symptoms, especially at first. and wounds. CollaGenex intends to pursue the research and development of these other applications primarily through partnerships with third parties. To receive additional information on the Company, please visit our Web site at www.collagenex.com, which is not a part of this press release. This news release contains certain forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. within the meaning of section 21E of the Securities and Exchange Act of 1934, as amended. Investors are cautioned that forward-looking statements involve risks and uncertainties, which may affect the Company's business and prospects. The Company's business of selling, marketing and developing pharmaceutical products is subject to a number of significant risks, including risks relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the implementation of the Company's sales and marketing plans for Periostat, risks inherent in research and development activities, risks associated with conducting business in a highly regulated environment and uncertainty relating to clinical trials of products under development, all as discussed in the Company's periodic filings with the U.S. Securities and Exchange Commission. |
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